Heart FailureTAILORD-HFNCT06847438
Tailored Electronic Intervention to Improve Therapy in a Diverse Cohort of Patients With Heart Failure
A study testing Optimized version of the EPIC-HF Checklist and Clinician-facing Decision Support in people with Heart Failure, run by Emory University at 4 sites in United States.
Trial summary
Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Optimized version of the EPIC-HF Checklist and Clinician-facing Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,966 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Mar 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ejection fraction (EF) less than or equal to 40% by echocardiogram performed in the prior 18 months
- Diagnosis of heart failure
Who cannot join
- Heart failure (HF) etiology for which GDMT is not indicated: including hypertrophic or restrictive cardiomyopathy (e.g. amyloid cardiomyopathy), constrictive pericarditis, or complex congenital heart disease
- End-stage HF requiring continuous inotrope infusion, heart transplant, or left ventricular assist device
- Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m^2
- Any conditions other than HF that are likely to alter the patient's status over 6 months, indicated by active hospice status
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30308
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
About this study
Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). However, studies have shown that these medications, known together as guideline-directed medical therapy (GDMT), are not being used in clinical practice less often than they could be. Several tools to promote broader use of these treatments (including patient checklists) have shown promise for increasing use of GDMT. However, these tools have not been broadly implemented within large health systems. The goal of this study is to see if using these tools broadly within cardiology clinics will increase the use of GDMT. This study is important because it could help improve the use of GDMT, which may lead to improved patient care and outcomes.
Read the detailed description
The 2022 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) and 2021 European Society of Cardiology (ESC) guidelines for the management of heart failure (HF) firmly establish that quadruple therapy with angiotensin receptor neprilysin inhibitors (ARNI), sodium glucose cotransporter-2 inhibitors (SGLT2i), evidence-based β-blockers, and mineralocorticoid receptor antagonists now form the foundational standard for guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF). Despite multiple randomized controlled trials establishing the clinical benefit of novel therapies like ARNI and SGLT2i, adoption of these novel therapeutic agents in clinical practice has been slower than expected. For example, a recent population-level cohort study using IQVIA Inc. National Prescription Audit data in the US showed that only 13.8% of patients with HFrEF were using sacubitril-valsartan from 2016-2019. Similarly, a recent retrospective cohort analysis of commercially insured patients with type 2 diabetes in the US demonstrated that only 8.7% were treated with an SGLT2i from 2015 to 2019. There is a need for interventions that increase utilization of these important medications.
The investigators have previously demonstrated a high burden of HF and suboptimal use of GDMT among a broad cohort of patients. There is a need to improve prescription of GDMT and to improve clinical outcomes for patients with HF with the use of evidence-based methods to improve care quality.
The EPIC-HF checklist is a patient activation tool that allows patients to see recommended doses and categories of GDMT, which they can use to compare to their current medications and dosing. In this implementation study, eight cardiology and heart failure clinics will be randomized to implement the EPIC-HF checklist or to perform standard of care for two 6-month periods. During the first 6-month period, patients will be provided with the EPIC-HF checklist prior to their clinic appointment via EMR message. During the second 6-month period, clinician-facing decision support for GDMT intensification will be added.
- Conditions
- Heart Failure
- Being tested
- Optimized version of the EPIC-HF Checklist, Clinician-facing Decision Support, Standard of Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized version of the EPIC-HF ChecklistBehavioural
The EPIC-HF checklist is a 1-page patient activation tool that contains approved and guideline-recommended medications and target doses for HFrEF. The EPIC-HF checklist allows patients to see recommended doses and categories of GDMT, which they can compare to their current medications and dosing. The EPIC-HF checklist has been refined and updated to include GDMT prescription and has been optimized for delivery through electronic medical record (EMR) systems. The checklist is being used as a patient activation/ discussion tool only and data entered on the checklist will not be collected for purposes of this study.
Clinician-facing Decision SupportBehavioural
Information regarding GDMT (including target doses and medications) analogous to what is contained in the checklist will be provided to clinicians in intervention clinics. This information will be visible at the time of the encounter.
Standard of CareBehavioural
Patients of clinics that are not implementing EPIC-HF checklist will not have the checklist available to them through the electronic medical record (EMR).
| Study group | Role | What they receive |
|---|---|---|
| Optimized version of the EPIC-HF Checklist | Other | Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. Receives: Behavioral: Optimized version of the EPIC-HF Checklist |
| EPIC-HF Checklist for Patients and Clinician-facing Decision Support | Other | Patients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. During this period of the study, clinicians in intervention clinics will also have access to analogous decision-support via EMR. Receives: Behavioral: Optimized version of the EPIC-HF Checklist; Behavioral: Clinician-facing Decision Support |
| Standard of Care | Active comparator | Patients of clinics that are randomized to the standard of care will not have the EPIC-HF checklist available for viewing in their electronic medical record (EMR). Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with GDMT Initiation or Intensification
Changes in medication are assessed as the initiation or intensification of recommended heart failure medications including foundational GDMTs (angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB)/angiotensin receptor neprilysin inhibitors (ARNI), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium glucose cotransporter-2 inhibitors (SGLT2i)) as well as other guideline recommended therapies for HFrEF including ivabradine, digoxin, and soluble guanylate cyclase stimulators.
Measured: 30 Days after Clinic Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start24 Mar 2025
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinics will be randomly assigned to implement the checklist or to not implement the checklist.
- Masking
- None (open label)
- Enrolment
- 3,966 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Neal Dickert, Emory University
- Investigators
- Neal W Dickert, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847438
- Sponsor's protocol ID
- STUDY00006716
- Other IDs
- 2025P013491
- Acronym
- TAILORD-HF
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data that underlie the results reported will be made available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Electronic Intervention to Improve Therapy in a Diverse Cohort of Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06847438
- Acronym / sponsor ID
- TAILORD-HF / STUDY00006716
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,966 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent medical guidelines for the management of heart failure (HF) have established a combination of specific classes of medications as the best treatment for patients with heart failure with reduced ejection fraction (HFrEF). However, studies have shown that these medications, known together as guideline-directed medical therapy (GDMT), are not being used in clinical practice less often than they could be. Several tools to promote broader use of these treatments (including patient checklists) have shown promise for increasing use of GDMT. However, these tools have not been broadly implemented within large health systems. The goal of this study is to see if using these tools broadly within cardiology clinics will increase the use of GDMT. This study is important because it could help improve the use of GDMT, which may lead to improved patient care and outcomes.
Detailed description
The 2022 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) and 2021 European Society of Cardiology (ESC) guidelines for the management of heart failure (HF) firmly establish that quadruple therapy with angiotensin receptor neprilysin inhibitors (ARNI), sodium glucose cotransporter-2 inhibitors (SGLT2i), evidence-based β-blockers, and mineralocorticoid receptor antagonists now form the foundational standard for guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF). Despite multiple randomized controlled trials establishing the clinical benefit of novel therapies like ARNI and SGLT2i, adoption of these novel therapeutic agents in clinical practice has been slower than expected. For example, a recent population-level cohort study using IQVIA Inc. National Prescription Audit data in the US showed that only 13.8% of patients with HFrEF were using sacubitril-valsartan from 2016-2019. Similarly, a recent retrospective cohort analysis of commercially insured patients with type 2 diabetes in the US demonstrated that only 8.7% were treated with an SGLT2i from 2015 to 2019. There is a need for interventions that increase utilization of these important medications.
The investigators have previously demonstrated a high burden of HF and suboptimal use of GDMT among a broad cohort of patients. There is a need to improve prescription of GDMT and to improve clinical outcomes for patients with HF with the use of evidence-based methods to improve care quality.
The EPIC-HF checklist is a patient activation tool that allows patients to see recommended doses and categories of GDMT, which they can use to compare to their current medications and dosing. In this implementation study, eight cardiology and heart failure clinics will be randomized to implement the EPIC-HF checklist or to perform standard of care for two 6-month periods. During the first 6-month period, patients will be provided with the EPIC-HF checklist prior to their clinic appointment via EMR message. During the second 6-month period, clinician-facing decision support for GDMT intensification will be added.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Clinics will be randomly assigned to implement the checklist or to not implement the checklist.
| Arm | Type | Receives |
|---|---|---|
| Optimized version of the EPIC-HF Checklist | Other | Behavioral: Optimized version of the EPIC-HF ChecklistPatients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. |
| EPIC-HF Checklist for Patients and Clinician-facing Decision Support | Other | Behavioral: Optimized version of the EPIC-HF Checklist, Behavioral: Clinician-facing Decision SupportPatients of clinics that are randomized to implement the checklist will be sent the checklist in advance of their visit via their electronic medical record (EMR) portal. During this period of the study, clinicians in intervention clinics will also have access to analogous decision-support via EMR. |
| Standard of Care | Active comparator | Behavioral: Standard of CarePatients of clinics that are randomized to the standard of care will not have the EPIC-HF checklist available for viewing in their electronic medical record (EMR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ejection fraction (EF) less than or equal to 40% by echocardiogram performed in the prior 18 months
- Diagnosis of heart failure
Key exclusion criteria (4 listed)
- Heart failure (HF) etiology for which GDMT is not indicated: including hypertrophic or restrictive cardiomyopathy (e.g. amyloid cardiomyopathy), constrictive pericarditis, or complex congenital heart disease
- End-stage HF requiring continuous inotrope infusion, heart transplant, or left ventricular assist device
- Estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m^2
- Any conditions other than HF that are likely to alter the patient's status over 6 months, indicated by active hospice status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized version of the EPIC-HF ChecklistThe EPIC-HF checklist is a 1-page patient activation tool that contains approved and guideline-recommended medications and target doses for HFrEF. The EPIC-HF checklist allows patients to see recommended doses and categories of GDMT, which they can compare to their current medications and dosing. The EPIC-HF checklist has been refined and updated to include GDMT prescription and has been optimized for delivery through electronic medical record (EMR) systems. The checklist is being used as a patient activation/ discussion tool only and data entered on the checklist will not be collected for purposes of this study. | Behavioural | EPIC-HF Checklist for Patients and Clinician-facing Decision Support, Optimized version of the EPIC-HF Checklist |
| Clinician-facing Decision SupportInformation regarding GDMT (including target doses and medications) analogous to what is contained in the checklist will be provided to clinicians in intervention clinics. This information will be visible at the time of the encounter. | Behavioural | EPIC-HF Checklist for Patients and Clinician-facing Decision Support |
| Standard of CarePatients of clinics that are not implementing EPIC-HF checklist will not have the checklist available to them through the electronic medical record (EMR). | Behavioural | Standard of Care |
Primary outcome
Number of Participants with GDMT Initiation or Intensification
Time frame: 30 Days after Clinic Visit
Changes in medication are assessed as the initiation or intensification of recommended heart failure medications including foundational GDMTs (angiotensin-converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB)/angiotensin receptor neprilysin inhibitors (ARNI), beta-blockers (BB), mineralocorticoid receptor antagonists (MRA), and sodium glucose cotransporter-2 inhibitors (SGLT2i)) as well as other guideline recommended therapies for HFrEF including ivabradine, digoxin, and soluble guanylate cyclase stimulators.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data that underlie the results reported will be made available for sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal W Dickert, MD, PhD principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized version of the EPIC-HF Checklist and Clinician-facing Decision Support in people with Heart Failure, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with GDMT Initiation or Intensification (time frame: 30 Days after Clinic Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.